IntubationNCT04003727
Glottic Visualisation During Laryngoscopy
A study testing Mcgrath Mac Videolaryngoscope in people with Intubation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation
- What is being tested?
- Mcgrath Mac Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2019to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18-65 aged
- Being obese
- Undergoing surgery under general anesthesia
Who cannot join
- Having difficult airway
- Being American Society of Anesthesiologist (ASA) 4 physical status
- Undergoing emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Hospital
Tokat Province, Merkez, 60100
About this study
Official title: The Effect of Head Position on Glottic Visualisation and Intubation Success With Videolaryngoscope in Obese Patients
In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients.
Read the detailed description
Tree different head and neck positions will compare for glottic visualization and intubation success rates in obese patients (BMI> 30 kg / m2) who required endotracheal intubation for general anesthesia between 18-65 years of age.
- Conditions
- Intubation
- Being tested
- Mcgrath Mac Videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mcgrath Mac VideolaryngoscopeDevice
Patient's laryngoscopy will be done using McGrath Mac video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Neutral Position | Active comparator | Head and neck will be on neutral position. Receives: Device: Mcgrath Mac Videolaryngoscope |
| Sniffing Position | Active comparator | Head and neck will be on sniffing position Receives: Device: Mcgrath Mac Videolaryngoscope |
| Head Extension position | Active comparator | Head will be on simple extension position Receives: Device: Mcgrath Mac Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glottic view
the percentage of glottic opening (POGO) and cormack-lehane scores will be used to rate of the glottic view
Measured: During laryngoscopy
Intubation Success
Intubation attempt number will be recorded
Measured: During intubation
Secondary outcomes (2)
Intubation difficulty
Intubation Difficulty Scale(IDS) score will be recorded.The IDS score is derived from seven variables. N1 represents the number of additional intubation attempts, N2 represents the number of additional operators, N3 is the number of alternative intubation techniques used; N4 represents the laryngoscopic view, N5 represents the lifting force applied during laryngoscopy, N6 represents the necessity to apply external laryngeal pressure to optimize glottic exposure, N7 represents the mobility of vocal cord. The IDS score is the sum of all variables and ranges from zero to infinity. A score of 0 indicates an easy tracheal intubation. Intubation is considered difficult if the score is greater than 5.
Measured: During Laryngoscopy
Intubation time
The duration of the endotracheal tube placement will be recorded
Measured: During Intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start10 Jul 2019
- Primary completion10 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tugba Karaman, MD, Principal investigator, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003727
- Sponsor's protocol ID
- 19-KAEK-085
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2019
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Position on Glottic Visualisation and Intubation Success With Videolaryngoscope in Obese Patients
- ClinicalTrials.gov ID
- NCT04003727
- Acronym / sponsor ID
- 19-KAEK-085
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients.
Detailed description
Tree different head and neck positions will compare for glottic visualization and intubation success rates in obese patients (BMI> 30 kg / m2) who required endotracheal intubation for general anesthesia between 18-65 years of age.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral Position | Active comparator | Device: Mcgrath Mac VideolaryngoscopeHead and neck will be on neutral position. |
| Sniffing Position | Active comparator | Device: Mcgrath Mac VideolaryngoscopeHead and neck will be on sniffing position |
| Head Extension position | Active comparator | Device: Mcgrath Mac VideolaryngoscopeHead will be on simple extension position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18-65 aged
- Being obese
- Undergoing surgery under general anesthesia
Key exclusion criteria (3 listed)
- Having difficult airway
- Being American Society of Anesthesiologist (ASA) 4 physical status
- Undergoing emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mcgrath Mac VideolaryngoscopePatient's laryngoscopy will be done using McGrath Mac video laryngoscope | Device | Head Extension position, Neutral Position, Sniffing Position |
Primary outcome
Glottic view
Time frame: During laryngoscopy
the percentage of glottic opening (POGO) and cormack-lehane scores will be used to rate of the glottic view
Intubation Success
Time frame: During intubation
Intubation attempt number will be recorded
2 secondary outcomes
Intubation difficulty
Time frame: During Laryngoscopy
Intubation time
Time frame: During Intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tugba Karaman, MD principal investigator
Tokat Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mcgrath Mac Videolaryngoscope in people with Intubation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glottic view (time frame: During laryngoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.